Pamedic Spotlight｜Voices of the Two Sessions——Scientific, Safe and Efficient Development of the Nuclear Drugs Industry

During the Two Sessions of the National People's Congress, a series of important proposals have been put forward by the representatives of government and expert in order to promote the field of nuclear drugs in more scientific, safe and efficient direction.

1.Li Qiang, Premier of the State Council (PRC): To Accelerate the Development of Innovative Drugs

In the government work report, in order to promote the upgrading of China's economy and optimization of the industrial structure, Premier Li Qiang emphasized the government's active cultivation of new and future industries, mentioning the need to accelerate the development of cutting-edge emerging hydrogen energy, new materials, innovative drugs and other industries, as well as to actively build a new engine of growth in bio-manufacturing, commercial spaceflight, and low-altitude economy.

2. Wang Rui, Academician, Chinese Academy of Engineering: To Strengthen the Construction of Nuclear Drugs system

Academician Wang Rui pointed out that there are problems such as insufficient original innovation ability, lack of kinetic energy for continuous innovation and insufficient empowerment of innovation system and mechanism in the field of nuclear drugs in China. Therefore, in order to strengthen the construction of organized scientific research and innovation system in the field of nuclear drugs, and to enhance China's independent innovation capability in the field of nuclear drugs, Academician Wang Rui put forward with two suggestions.

(1) Strengthening the organized scientific research and innovation system in the field of nuclear pharmacy, and enhancing the capability of independent innovation

It is suggested to set up a national strategic Advisory committee for nuclear pharmacy led by academicians, compile a report on the development innovation index of nuclear medicine in China, and form suggestions for the development of the industry through improving the accuracy of government funding, and increase the orientation and continuous support for key platform work and source innovation work that promote the original innovation ability of nuclear drugs; strengthening the construction of innovative talent echelon, and establish a new professional degree of Doctor of radiation pharmacy; encouraging research institutes and researchers to jointly tackle key problems in response to the needs of enterprises, and establishing a new mechanism for evaluating scientific and technological achievements.

(2) Developing “new quality productivity” in the field of nuclear drugs driven by ideas and scientific and technological innovations

It is recommended to carry out research on the development law and characteristics of nuclear drugs, and form a guiding ideology for the innovative development of nuclear drugs with Chinese characteristics; to comprehensively implement the project of upgrading the new quality productivity of nuclear drugs, guide enterprises and social capital to invest in new growth poles, and form a batch of growth points of new quality productivity with the potential to lead the world; and to encourage the construction of a comprehensive national nuclear drugs R&D body with the deep integration of the government, industry, academia, research, and drugs, relying on the platforms of the National Key Laboratory of Pharmacy and bring in government and social capital to cultivate it into a scientific and technological innovation entity with the potential to influence the pattern of the development of international nuclear drugs.

3.Li Sijin, Vice Chairman of the Shanxi Provincial Committee of the Chinese People's Political Consultative Conference (CPPCC): To Improve the Management System of Nuclear Drugs Applications

Commissioner Li Sijin is concerned about the importance of nuclear drugs in modern drugs, especially its irreplaceable role in the early and precise diagnosis, treatment, efficacy monitoring and guidance of individualized treatment of major diseases (e.g., tumors, cardiovascular, and central nervous system disorders, etc.), and suggests:

(1) Nuclides, precursors/ligands, nuclide generators, etc. can be managed with reference to APIs or functional excipients,produced in GMP-compliant pharmaceutical factories, registered in Drug Manufacturing License, registration requirements are managed with reference to DMF (Drug Master File). Considering the characteristics of cold pill box, it is suggested that the production of cold pill box should be regulated with reference to the lyophilized powder injection preparation for general injection, and can be produced in parallel with the lyophilized powder injection preparation for general injection under the premise of meeting the technical conditions. The holder of the cartridge is allowed to entrust the manufacturer of generic drugs to carry out the production of cold cartridges, and both the production of cold cartridges and the production of lyophilized powdered needle preparations for general injection can be issued with a Drug Production License and a Radioactive Drug Production License at the same time.

(2) Formulate standard of prices in accordance with characteristics of different radionuclides in terms of the attenuation and clinical use.

(3) Incorporate more nuclear drugs into the national health insurance reimbursement catalog to better meet clinical diagnostic and therapeutic needs.

4. Han Yongjiang, Chairman of Tongfang Co., Ltd., China Baoyuan Investment Co., Ltd.: To Strengthen Innovation in Nuclear Technology Applications

Commissioner Han Yongjiang emphasized the comprehensive nature of the nuclear technology application industry and its close relationship with the national economy, suggesting:

(1) To continuously strengthen the top-level design and overall planning of the nuclear technology application industry at the national level, and to enhance the systematic, forward-looking and directional nature of industrial development. Relying on the competent department of the nuclear industry, a competent organization for the development of the nuclear technology application industry should be set up to be responsible for the supervision and management of the whole industrial chain, as well as the liaison and coordination with relevant departments and enterprises. And the interface between the industry and the management of other industries such as environmental protection, transportation, public security, health care and food and drugs should be opened up. Formulate an overall plan in time for the development of the nuclear technology application industry that is in line with national conditions and conducive to technological innovation, clarification of the key directions and layout of industrial development, and the introduction of more guiding documents on medium- and long-term development planning for the application of nuclear technology in specific areas, referring to the “Mid-to-Long-Term Development Plan for Medical Isotopes (2021-2035)”.

(2) To further strengthen the construction of innovative basic capabilities in the nuclear technology application industry, set up a national major scientific and technological special project on nuclear technology application to support basic, cutting-edge and high-value applied research on nuclear technology; and build a number of breakthrough and platform-type scientific research institutes, or clusters of scientific research facilities, for the nuclear technology application industry. For example, in isotope products, original nuclear drugs, high-end medical equipment, advanced detectors and gas pedals, precision nuclear instrumentation and other related fields, there is a need for integrated consideration to carry out research and development platforms, major scientific research projects and promotion, to create a "source" of original technology for the nuclear technology application industry, and to inject a strong impetus for the development of the industry.

5.Looking into the Future

During the Two Sessions, the suggestions made by representatives on the nuclear drugs industry reflected their continued concern and attention to its development. Last year, Commissioner Li Sijin and other members put forward a proposal on the development of nuclear drugs and radiopharmaceuticals, which was promptly replied and adopted by the State Drug Administration (SDA), demonstrating the government's great attention to the industry. This year, during the Two Sessions, representatives such as Academician Wang Rui, Commissioner Li Sijin, and Commissioner Han Yongjiang have also made suggestions for the innovative development of nuclear drugs with purpose of actively promoting the development of the nuclear drug industry by proposing policy recommendations and technological innovation programmes.

As a nuclear medicine development company, Pamedic Holdings is fully aware that the advice of the representatives will help lead the nuclear medicine industry towards a more scientific, safe and efficient development. We will regard the these suggestions as a guideline, continue to follow the policy dynamics, and actively respond to the call of the state to continuously improve the technical level and strengthen the innovation ability so as to ensure the scientificity, safety and high efficiency of the nuclear medicine products, committed to promoting the development of the nuclear drug industry in a more healthy and sustainable direction.